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Completed

NCT Number: NCT04503408

A Comparison of Clinical Parameters in With and Without Abnormal Glucose Tolerance.

Cystic fibrosis (CF) is autosomal recessive, genetic disorder cause of cystic fibrosis transmembrane regulatory (CFTR) gene mutation. CF often is observed in caucasian population. CFTR protein in cell apical membrane is canal responsible of transport sodium and clorid ions. Impaired sodium ion transport causes production viscous mucus. Disease include problems such as mucus, breathlessness and coughing. Blood glucose levels fluctuation are observed. This study aims comparison between lung function, functional capacity, muscle strength, physical activity, physical fitness and activities of daily living activities in cystic fibrosis with and without abnormal glucose tolerance

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Key information

Conditions

Cystic Fibrosis-related Diabetes Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Infant, Newborn, Diseases Lung Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elif Kocaaga

Ankara, 06230, Turkey (Türkiye)

About this study

The study aimed that comparison of clinical parameters in children with and without abnormal glucose tolerance in Cystic fibrosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cystic fibrosis with impaired glucose tolerance or cystic fibrosis-related diabetes for Abnormal glucose tolerance group
  • Cooperation for tests
  • Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests,
  • To volunteer for the study.

For the control group

  • Cystic fibrosis with normal glucose tolerance
  • Cooperation for tests
  • Indıviduals without an orthopedic or neurological problem and serious cardiac problems that effecting tests,
  • To volunteer for the study.

Exclusion criteria

Patients having following disease

  • Acute pulmonary exacerbation
  • Acute or chronic respiratory failure
  • FEV₁ lower than %40
  • Cooperation problems,
  • Bronchopulmonary aspergillus and using steroid.

Treatment and study plan

Primary outcomes

  1. Distance of 6 minute walk test

    Time frame: 28 week

    Distance of 6 minute walk test assesing functional capacity made on flat corridor with speed is determined from participant. She/he walks during 6 minute on this corridor as quickly as possible.

  2. Lung function

    Time frame: 28 week

    Lung function will be assesed for standardization procedure in Cystic fibrosis. Acceptible outcome will be recorded.

  3. Respiratory muscle strength

    Time frame: 28 week

    Both inspiratory and expiratory muscle strength wil be evaluated at least three times in Cystic fibrosis. Mouth pressure device will be used for evaluate. The highest value for MIP and MEP will be recorded.

  4. Quadriceps muscle strength

    Time frame: 28 week

    Quadriceps muscle strength will be assessed least three times in children with cystic fibrosis. hand held dynamometer will be used for assessing quadriceps muscle strength. The highest value for each side will be recorded and used for analysis.

  5. Handgrip

    Time frame: 28 week

    Handgrip will be assessed in Cystic fibrosis using hand dynamometer (Jamar hand dynamometer). Assessing will be repeated three times end mean of three measurement will be calculated and used for analysis.

  6. Physical activity levels

    Time frame: 28 week

    Physical activity will be evaluated with Bouchard physical activity record. This activity recorder is evaluated every 15 min in a day. Two weekday and one weekend day are recorded with made activity.

  7. Physical fitness

    Time frame: 28 week

    Physical fitness is measured with Munich physical fitness test battery. This battery vertial jump, bouncing ball, flexibilty, climbing, throwing bag, step up test are included in battery. the battery evaluates such as strength, endurance, speed, flexibilty, coordination, power.

  8. Distance of shuttle walk test

    Time frame: 28 week

    Distance of shuttle walk test will be walked by children with cystic fibrosis. Shuttle walk test is made on floor with ten meters distance. Speed is determined according to signals from CD player.

  9. Time of activities of daily living test

    Time frame: 28 week

    Activities of daily living will be tested with the Glittre ADL test. This test includes five repeated cycles that includes sitting, walk, step up and changing place of object on bookshelf in test procedure. The total completion time of five cycles will be recorded and used for analysis

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

A Comparison of Pulmonary Function, Functional Capacity, Muscle Strength, Physical Activity, Physical Fitness and Activities of Daily Living in Cystic Fibrosis Patient's With and Without Abnormal Glucose Tolerance.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2020
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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